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The eClinical Forum is a global network of peers. It provides a non‐competitive environment for innovation, learning and collaboration in clinical research.

NEWS FROM THE ECF

Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments

18 September 2024
Author: Suzanne Bishop (Americas Administrator)
Number of views: 441
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Recording available from our public webinar which provided information on our 3 free tools: The “eCF Requirements” (Requirements for electronic data for regulated clinical trials), eSRA (Site eSource-Readiness Assessment), and ISF (Investigator Site File System) Assessment. These tools are absolutely free to download as a service to the industry that we serve; we do not even collect email or other information.

Japan Society for Medical Informatics

26 August 2021
Author: Kenichi Nakano
Number of views: 2205
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eSRA was used in a Japanese research paper on data quality of medical information systems

Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."

eCF published in Applied Clinical Trials 16-June-2021

17 June 2021
Author: Suzanne Bishop (Americas Administrator)
Number of views: 3362
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Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?" It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

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eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification (21/11/2024 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
21/11/2024
eCF Birds-of-a-Feather Round-Table: Risk-Based Source Data Verification
This topic is coming out of a discussion that started at the eCF Workshop in Massachusetts in October. The group decided they wanted more time to delve more deeply into this discussion and to include eCF members from other regions. The discussion will be around:

100% SDV provides little value for a whole lot of work … but how do we define “critical” data such that not everything is considered critical?

How can we implement a risk-based approach without compromising down-stream activities?
Read more
eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members (05/12/2024 (UTC+00:00) Dublin, Edinburgh, Lisbon, London)
05/12/2024

eCF “Think GCP” Webinar: ICH E6(R3) for eCF Members

Presenter: Rebecca Stanbrook, GCP Strategic Lead, Process & Risk Surveillance, Novartis, EFPIA Topic Lead ICH E6(R3)

About this topic: The final piece of the GCP renovation puzzle, revision 3 of ICH GCP. Understand the background to the renovation, key changes and the philosophy of the changes in this one hour webinar.
Read more

NEWS FROM THE ECF

Recording of eCF Public Webinar: Regulatory Requirements for Electronic Data/Systems for Clinical Trials, and associated site system assessments

eSRA was used in a Japanese research paper on data quality of medical information systems

Japan Society for Medical Informatics

"When should audit trail begin?"

eCF published in Applied Clinical Trials 16-June-2021

Upcoming events Events RSSiCalendar export

Upcoming events Events RSS iCalendar export